bad medical devices blog

According to a recent Philadelphia Daily News article, the Supreme Court approved the release of Michael Mastromarino, the accused ringleader of a body parts tissue scam, without posting bail.
Mastromarino, was the owner Biomedical Tissue Services, Inc., which allegedly purchased tissue of 244 diseased Philadephians without the approval of the deceased or their relatives.  The company […]

Per a recent Reuters article,  an investor has filed a lawsuit against Abbott Laboratory seeking more than $70 million in damages.  The investor, Birmingham Associates, alleges Abbott breached an obligation by discontinuing its ZoMaxx stent.  Abbott stopped development of the ZoMaxx stent in October 2006 and said it would focus on developing another drug-coated stent […]

Medtronic, the company whose recently recalled Sprint Fidelis leads have killed five people and injured many more, has been approved to sell its Sprint Quattro leads in Japan.  The Quattro lead has been in use in the U.S. and in Europe since 2001.  Although many doctors had been using the Fidelis leads for their smaller […]

Reports to the FDA of two children’s deaths due to meningitis from cochlear implants with positioners led to the recall of July 2002. The deaths of these children, ages 9 and 11, could have been prevented through proper meningitis vaccination.  Neither child was fully vaccinated.  The FDA is again reminding all implanted patients at risk […]

Per a recent press release, Consumers Union has filed a petition with the FDA requesting it require all advertisements for implantable devices — such as knee, hip and heart valve replacements, cosmetic implants and heart stents — carry a warning about the possibility of dangerous infections or failures of the devices once they are in […]

Per a recent Reuters article,  a U.S. expert advisory panel has expressed concerns about the effectiveness of an experimental sterilization device made by Hologic.  The panel called the company’s data inconclusive.  The device, called Adiana, uses a catheter to implant a silicone device in the Fallopian tubes to prevent pregnancy.
“There is some difficulty with a […]

On December 13, the FDA informed healthcare professionals about serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces during dental procedures. Some patients had third degree burns which required plastic surgery. Burns may not be apparent to the operator or the patient until after the tissue damage […]

The FDA has announced that it plans to issue new requirements for the testing of drug coated stents.  The new requirements will likely require longer testing periods and require that the stents be tested on a larger number of people.  The recommended time that patients should take the anticlotting drug Plavix after getting a new […]

The FDA has reported that patients have died when surgeons use a medical device to remove lung tumors. All the reports involved ablation surgery to eliminate lung tumors, a use the agency has not approved.
The FDA said it has received reports of deaths connected with radio-frequency ablation systems, which generate extreme heat to destroy diseased […]

Per a recent article at Product Liability Law360 (http://productliability.law360.com/Secure/ViewArticle.aspx?id=40947),
Seven plaintiffs who sued Becton Dickinson & Co. and a McKesson Corp.
subsidiary after losing at least part of their eyesight from a contaminated syringe have dismissed their product liability suit with prejudice against the companies.
The motion comes after the parties reached a settlement in early October through […]